BS EN ISO 20417:2021 PDF Download

• All parts of the medical devices industry
• CEOs, compliance and legal teams in the medical devices industries
• Regulators

Why should you use BS EN ISO 20417:2021?

It specifies the information to be supplied by medical device or medical device accessory manufacturers. It covers general requirements, medical device identification, requirements for packaging, requirements for marking and information on the label, and requirements for accompanying documentation.

BS EN ISO 20417:2021 aims to serve as a central source of these common, generally applicable requirements, allowing each specific product standard or group standard to focus more concisely on the unique requirements for a specific medical device or group of medical devices. The requirements of a medical device product standard or a group standard can make use of these general requirements.

Use of the standard can help medical device manufacturers:

• Comply with the requirements of the MDR
• Enter new markets
• Develop their product information expertise
• Facilitate trade
• Manage risk
• Increase trust in their products

NOTE: Some authorities with jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory. Specific requirements of medical device product standards or group standards take precedence over the requirements of this document.

BS EN ISO 20417:2020 contributes to UN Sustainable Development Goal 3 on ensuring healthy lives and promoting well-being for all at all ages. This goal looks for the provision of quality healthcare, and also of equipment that helps healthcare providers deliver a safe, reliable and effective service, which is what this standard supports.